title: HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial.
abstract: BACKGROUND
  The HeartWare Ventricular Assist System (HeartWare Inc, Framingmam, MA) is a miniaturized implantable, centrifugal design, continuous-flow blood pump. The pivotal bridge to transplant and continued access protocols trials have enrolled patients with advanced heart failure in a bridge-to-transplant indication.
  
  
  METHODS
  The primary outcome, success, was defined as survival on the originally implanted device, transplant, or explant for ventricular recovery at 180 days. Secondary outcomes included an evaluation of survival, functional and quality of life outcomes, and adverse events.
  
  
  RESULTS
  A total of 332 patients in the pivotal bridge to transplant and continued access protocols trial have completed their 180-day primary end-point assessment. Survival in patients receiving the HeartWare pump was 91% at 180 days and 84% at 360 days. Quality of life scores improved significantly, and adverse event rates remain low.
  
  
  CONCLUSIONS
  The use of the HeartWare pump as a bridge to transplant continues to demonstrate a high 180-day survival rate despite a low rate of transplant. Adverse event rates are similar or better than those observed in historical bridge-to-transplant trials, despite longer exposure times due to longer survival and lower transplant rates.
authors.affiliation: Division of Cardiothoracic Surgery and Department of Medicine, University of Louisville, Louisville, Kentucky 40202, USA. mark.slaughter@louisville.edu
authors.forename: Mark S
authors.initials: MS
authors.lastname: Slaughter
authors.forename: Francis D
authors.initials: FD
authors.lastname: Pagani
authors.forename: Edwin C
authors.initials: EC
authors.lastname: McGee
authors.forename: Emma J
authors.initials: EJ
authors.lastname: Birks
authors.forename: William G
authors.initials: WG
authors.lastname: Cotts
authors.forename: Igor
authors.initials: I
authors.lastname: Gregoric
authors.forename: O
authors.initials: O
authors.lastname: Howard Frazier
authors.forename: Timothy
authors.initials: T
authors.lastname: Icenogle
authors.forename: Samer S
authors.initials: SS
authors.lastname: Najjar
authors.forename: Steven W
authors.initials: SW
authors.lastname: Boyce
authors.forename: Michael A
authors.initials: MA
authors.lastname: Acker
authors.forename: Ranjit
authors.initials: R
authors.lastname: John
authors.forename: David R
authors.initials: DR
authors.lastname: Hathaway
authors.forename: Kevin B
authors.initials: KB
authors.lastname: Najarian
authors.forename: Keith D
authors.initials: KD
authors.lastname: Aaronson
mesh_terms: D002985:Clinical Protocols; D004867:Equipment Design; D005260:Female; D006333:Heart Failure / Q000601:surgery*; D016027:Heart Transplantation; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014850:Waiting Lists